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Charlotte Retention in Care Study

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ClinicalTrials.gov Identifier: NCT03584048
Recruitment Status : Unknown
Verified July 2018 by Epividian.
Recruitment status was:  Enrolling by invitation
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Epividian

Tracking Information
First Submitted Date May 17, 2018
First Posted Date July 12, 2018
Last Update Posted Date July 12, 2018
Actual Study Start Date July 1, 2018
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 10, 2018)
Engagement level [ Time Frame: 12 months, 01-Nov-2018 to 31-Oct-2019 ]
Pre and post-baseline engagement level. Engagement level is defined as patients with 0, 1, or 2+ visits to physician (identified as a visit that included the collection of 1 viral load and/or 1 CD4 count lab test).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 10, 2018)
Kept appointment [ Time Frame: 12 months, 01-Nov-2018 to 31-Oct-2019 ]
Pre and post-baseline "kept appointment rate", the proportion of patients who attended their scheduled office visits.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Charlotte Retention in Care Study
Official Title Charlotte Retention in Care Study - Clinical Decision Support System Prompts
Brief Summary The objective of the Charlotte Retention in Care study is to assess if clinical decision support systems (CDSS) that produce standardized alerts for measures of retention in care across clinics in the city of Charlotte, North Carolina have the ability to increase retention in care measures within clinics and in surveillance reports.
Detailed Description Multiple Charlotte HIV Clinic providers are participating. "Primary" HIV provider will be defined as the primary physician or advanced care practitioner following a patient, as recorded in their respective Electronic Health Record (EHR) system and identified through CHORUS, a Clinical Decision Support System (CDSS) developed by Epividian. The CDSS will track patient case status as active or inactive (loss to follow-up, transferred medical care, or deceased). Providers will be informed of the study and sites will be contracted to participate in this collaborative research study. This study was approved by the Advarra Institutional Review Board.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 17 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population HIV-1+, males, females, transgender, ≥18 years of age, residing in the Charlotte Metropolitan Area and with at least a single entry in the EHR in the last 2 years.
Condition HIV I Infection
Intervention Other: Alert to provider
Providers receive alerts of sub-optimal patient attendance using 4 rules.
Study Groups/Cohorts HIV-1
HIV-1+, males, females, transgender, ≥18 years of age, residing in the Charlotte Metropolitan Area and with at least a single entry in the EHR in the last 2 years.
Intervention: Other: Alert to provider
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 10, 2018)
6500
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 31, 2019
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • HIV-1+
  • Any gender
  • 18 years old or older
  • Residing in the Charlotte, North Carolina metropolitan area
  • At least a single entry in the EHR in the last 2 years
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03584048
Other Study ID Numbers HO-18-19095
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: No Protected Health Information (PHI) is shared outside of clinic. De-identified data available only to authorized researchers via Epividian Clinical Advisory Board approval.
Responsible Party Epividian
Study Sponsor Epividian
Collaborators ViiV Healthcare
Investigators
Principal Investigator: Michael Leonard, MD Atrium Health (Carolinas HealthCare System)
PRS Account Epividian
Verification Date July 2018